DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2Dr. Reddy's Laboratories
02 4Alfred E Tiefenbacher GmbH
03 2Medichem S.A
04 2Mankind Pharma
05 3ABEX Pharmaceutica
06 2Actavis Inc
07 2Ajanta Pharma Limited
08 2Alkem Laboratories
09 3Alphapharm PTY Ltd
10 9Apotex Inc
11 2ENDO OPERATIONS
12 3Farm Agon
13 2Hetero Drugs
14 2Indoco Remedies Limited
15 4Inventia Healthcare Limited
16 2Lupin Ltd
17 2MINT PHARMACEUTICALS INC
18 2Macleods Pharmaceuticals Limited
19 2Medley Pharmaceuticals
20 2NE RX PHARMA
21 4Nora Pharma
22 2Orchid Pharma
23 1Oyster Point Pharma
24 3Pfizer Consumer Healthcare
25 16Pfizer Inc
26 3Pharmacore Inc
27 2Piramal Pharma Solutions
28 3Sandoz B2B
29 2Teva Pharmaceutical Industries
30 2Viatris
31 2Zydus Lifesciences
01 4Antic-calc Tablet, Film Coated
02 3FCT
03 3FILM COATED PILL
04 4Film Coated Tablet
05 4KIT
06 1SPRAY;NASAL
07 5TAB
08 8TABLET
09 2TABLET; ORAL
10 34TABLET;ORAL
11 6Tablet
12 10tablet
13 10Blank
01 4DISCN
02 4EU Dossier Readiness-Q3 2019
03 3Generic
04 2Generic EU CTD
05 5Originator
06 10Prescription
07 29RX
08 37Blank
01 4APO-VARENICLINE
02 1CABREXXA 0,5
03 2CABREXXA 1
04 2CHANTIX
05 15Champix
06 2Champix 1mg
07 3Champix starter pack
08 2MINT-VARENICLINE
09 4NRA-VARENICLINE
10 3PHARMACOR VARENICLINE
11 1TYRVAYA
12 3VARENAPIX
13 2VARENICLINE
14 32VARENICLINE TARTRATE
15 3Varenicline Sandoz
16 3Varenicline Viatris
17 12Blank
01 15Australia
02 10Canada
03 4Germany
04 6India
05 3Italy
06 6Norway
07 8South Africa
08 2Spain
09 3Sweden
10 37USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2024-10-01
Application Number : 215931
Regulatory Info : RX
Registration Country : USA
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2023-08-01
Application Number : 214255
Regulatory Info : RX
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2024-10-01
Application Number : 215931
Regulatory Info : RX
Registration Country : USA
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2023-08-01
Application Number : 214255
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date :
Application Number : 201808
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date :
Application Number : 201808
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2024-03-19
Application Number : 213019
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2024-03-19
Application Number : 213019
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2023-08-23
Application Number : 214557
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2023-08-23
Application Number : 214557
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2023-01-25
Application Number : 201962
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2023-01-25
Application Number : 201962
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2023-10-23
Application Number : 214571
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2023-12-04
Application Number : 211862
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2023-12-04
Application Number : 211862
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TYRVAYA
Dosage Form : SPRAY;NASAL
Dosage Strength : EQ 0.03MG BASE/SPRAY
Packaging :
Approval Date : 2021-10-15
Application Number : 213978
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CHANTIX
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2006-05-10
Application Number : 21928
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CHANTIX
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2006-05-10
Application Number : 21928
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : VARENICLINE
Dosage Form : TABLET; ORAL
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number : 201920
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : VARENICLINE
Dosage Form : TABLET; ORAL
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number : 201920
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2024-02-28
Application Number : 202019
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2024-02-28
Application Number : 202019
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2021-08-11
Application Number : 201785
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2021-08-11
Application Number : 201785
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
